aTyr Pharma, Inc. (Nasdaq:LIFE), a biotherapeutics company engaged
in the discovery and development of innovative medicines based on
novel immunological pathways, today announced operating results for
the fourth quarter and year ended December 31, 2017.
“We achieved several key milestones in 2017 that will enable the
continued development of our ORCA and ATYR1923 programs, and allows
us to actively pursue our mission to develop and deliver innovative
therapeutics based on our knowledge of novel immunological
pathways,” said Sanjay Shukla, M.D., M.S., President and CEO of
aTyr Pharma. “These achievements included initiating the
development of a panel of antibodies from our ORCA immuno-oncology
program, and initiating the first-in-human clinical trial of
ATYR1923 for the potential treatment of immune-mediated lung
diseases. We look forward to announcing top-line results from the
Phase 1 study in healthy volunteers of ATYR1923 in the second
quarter of this year, and expect to present and publish additional
data in support of ORCA and ATYR1923 as we advance both programs in
2018.”
Program Highlights
- In November 2017, aTyr initiated a Phase 1, randomized,
double-blind, placebo-controlled study evaluating the safety,
tolerability, immunogenicity and pharmacokinetics of intravenous
ATYR1923 in healthy volunteers.
- aTyr expects to announce top-line results from this study in
the second quarter of 2018.
- In December 2017, aTyr selected a panel of antibodies for
continued preclinical development and initiated CMC activities from
its ORCA program.
- aTyr expects to initiate patient trials as early as 2019.
- In January 2018, aTyr presented data from its ORCA program
highlighting the potential importance of Resokine in
immuno-oncology at the American Society of Clinical Oncology –
Society for Immunotherapy of Cancer (ASCO-SITC) Clinical
Immuno-Oncology Symposium in San Francisco.
- Identification of Novel Liquid Biopsy Biomarker for Monitoring
the Immune Set Point in Both Solid Tumor and Hematological
Malignancy Patients
- In April 2018, aTyr will present additional data on its ORCA
program at the upcoming American Association for Cancer Research
(AACR) Annual Meeting in Chicago:
- April 16, 2018: Circulating levels of Resokine, a soluble
modulator of the immune system, are upregulated in both
experimental cancer models and in patients across multiple tumor
types
- April 17, 2018: Antibodies targeting Resokine, a soluble immune
modulator, inhibit tumor growth in syngeneic mouse models
Corporate Highlights
- In November 2017, aTyr appointed Sanjay Shukla, M.D., M.S., as
President and Chief Executive Officer.
- In February 2018, aTyr promoted David J. King, Ph.D. to Chief
Scientific Officer and Ashraf Amanullah, Ph.D. to Senior Vice
President, Biologics Development and Manufacturing.
Fourth Quarter 2017 Financial Results
Research and development expenses were $5.3 million and $9.1
million for the quarters ended December 31, 2017 and 2016,
respectively. The decrease of $3.8 million was due primarily to a
$1.3 million decrease related to manufacturing costs incurred in
support of ATYR1923 clinical studies, a $1.9 million decrease
related to the completion of ATYR1940 clinical studies, a decrease
of $0.9 million related to manufacturing costs incurred in support
of ATYR1940 clinical studies in the prior year, a $0.2 million
decrease related to non-cash stock-based compensation, and a $0.1
million decrease related to discovery research. The decrease was
partially offset by an increase related to ATYR1923 Phase 1
clinical study costs of $0.6 million.
General and administrative expenses were $5.9 million compared
to $3.4 million for the quarters ended December 31, 2017 and 2016,
respectively. The increase was primarily related to non-cash
stock-based compensation expense related to executive
transitions.
Full Year 2017 Financial Results Research
and development expenses were $30.1 million and $42.8 million for
the years ended December 31, 2017 and 2016, respectively. The
decrease of $12.8 million was due primarily to a $9.6 million
decrease related to manufacturing costs incurred in support of
ATYR1940, a $6.7 million decrease related to ATYR1940 clinical
trial costs, a $0.5 million decrease in discovery projects, and a
$0.5 million decrease in non-cash stock-based compensation expense.
The decrease was partially offset by an increase of $1.3 million
related to ATYR1923 Phase 1 clinical studies, a $1.2 million
increase related to research and non-clinical development costs
incurred for ATYR1923, a $1.1 million increase related to ORCA
pre-clinical and research activities and an increase of $0.8
million related to manufacturing costs incurred in support of
ATYR1923.
General and administrative expenses were $17.1 million and $15.1
million for the years ended December 31, 2017 and 2016,
respectively. The increase of $2.0 million was due primarily to a
$2.2 million increase in non-cash stock-based compensation expense
related to executive transitions, which was partially offset by a
reduction of $0.2 million in professional fees.
Financial GuidanceAs of December 31, 2017, aTyr
had $85.1 million in cash, cash equivalents and investments and
41.2 million shares of common stock outstanding on an if-converted
basis (includes 29.8 million shares of common stock and 11.4
million shares of common stock if converted from Class X Preferred
stock).
aTyr expects that its cash, cash equivalents and investments
will be sufficient to fund its anticipated operations into the
third quarter of 2019.
Conference Call and Webcast DetailsaTyr Pharma
will host a conference call and webcast today at 2:00 p.m. Pacific
Time / 5:00 p.m. Eastern Time to discuss the results and provide a
general corporate update. Interested parties may access the call by
dialing toll-free (844) 358-9116 from the US, or (209) 905-5951
internationally and using conference ID 3697758. Links to a live
audio webcast and replay may be accessed on the aTyr website events
page at: http://investors.atyrpharma.com/events-and-webcasts. An
audio replay will be available for at least 90 days following the
event.
About aTyr Pharma aTyr Pharma is engaged in the
discovery and development of innovative medicines using its
knowledge of newly discovered pathways in immunology effected by
extracellular tRNA synthetases. To date, aTyr has generated
innovative and unique development programs based on its knowledge
of extracellular histidyl-tRNA synthetase (HARS), known as the
Resokine pathway. aTyr’s clinical stage ATYR1923 candidate is an
agonist of the Resokine pathway designed to temper immune
engagement in interstitial lung diseases. aTyr’s preclinical
research stage ORCA program, targets a novel, proprietary
immuno-oncology pathway using antibodies to enhance the immune
response in tumor settings. aTyr has built an intellectual property
estate, to protect its pipeline, comprising over 250 issued patents
or allowed patent applications that are owned or exclusively
licensed, including over 300 potential protein compositions derived
from tRNA synthetase genes. For more information, please visit
http://www.atyrpharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Litigation Reform Act. Forward-looking statements are
usually identified by the use of words such as “anticipates,”
“believes,” “estimates,” “expects,” “intends,” “may,” “plans,”
“projects,” “seeks,” “should,” “will,” and variations of such words
or similar expressions. We intend these forward-looking statements
to be covered by such safe harbor provisions for forward-looking
statements and are making this statement for purposes of complying
with those safe harbor provisions. These forward-looking
statements, including statements regarding the potential
therapeutic benefits of ATYR1923 or potential product candidates
from our ORCA program, the ability of the Company to successfully
advance its pipeline or product candidates, undertake certain
development activities (such as clinical trial enrollment and the
conduct of clinical trials) and accomplish certain development
goals and the timing of such activities and development goals, the
timing of our clinical trials, our ability to receive regulatory
approvals for, and commercialize, our product candidates and of
reporting results from our clinical trials, the scope and strength
of our intellectual property portfolio and our projected cash
expenditures reflect our current views about our plans, intentions,
expectations, strategies and prospects, which are based on the
information currently available to us and on assumptions we have
made. Although we believe that our plans, intentions,
expectations, strategies and prospects as reflected in or suggested
by those forward-looking statements are reasonable, we can give no
assurance that the plans, intentions, expectations or strategies
will be attained or achieved. Furthermore, actual results may
differ materially from those described in the forward-looking
statements and will be affected by a variety of risks and factors
that are beyond our control including, without limitation, risks
associated with the discovery, development and regulation of our
product candidates, the risk that we may cease or delay preclinical
or clinical development activities for any of its existing or
future product candidates for a variety of reasons (including
difficulties or delays in patient enrollment in planned clinical
trials), and the risk that we may not be able to raise the
additional funding required for its business and product
development plans, as well as those set forth in our most recent
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in
our other SEC filings. Except as required by law, we assume no
obligation to update publicly any forward-looking statements,
whether as a result of new information, future events or
otherwise.
ATYR PHARMA INC. |
|
Condensed Consolidated Statements of
Operations |
|
(in thousands, except share and per share data) |
|
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|
|
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|
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Three Months
Ended |
|
|
Years Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
5,310 |
|
|
$ |
9,144 |
|
|
$ |
30,067 |
|
|
$ |
42,846 |
|
General
and administrative |
|
|
5,890 |
|
|
|
3,383 |
|
|
|
17,078 |
|
|
|
15,094 |
|
Total operating
expenses |
|
|
11,200 |
|
|
|
12,527 |
|
|
|
47,145 |
|
|
|
57,940 |
|
Loss from
operations |
|
|
(11,200 |
) |
|
|
(12,527 |
) |
|
|
(47,145 |
) |
|
|
(57,940 |
) |
Other
income (expense), net |
|
|
(274 |
) |
|
|
(59 |
) |
|
|
(1,062 |
) |
|
|
65 |
|
Loss on
extinguishment of debt |
|
|
— |
|
|
|
(29 |
) |
|
|
— |
|
|
|
(29 |
) |
Other
income (expense) |
|
|
(274 |
) |
|
|
(88 |
) |
|
|
(1,062 |
) |
|
|
36 |
|
Loss before income
taxes |
|
|
(11,474 |
) |
|
|
(12,615 |
) |
|
|
(48,207 |
) |
|
|
(57,904 |
) |
Income
tax benefit |
|
|
— |
|
|
|
49 |
|
|
|
— |
|
|
|
49 |
|
Net loss |
|
$ |
(11,474 |
) |
|
$ |
(12,566 |
) |
|
$ |
(48,207 |
) |
|
$ |
(57,855 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.87 |
) |
|
$ |
(2.44 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
|
29,768,259 |
|
|
|
23,716,904 |
|
|
|
25,799,853 |
|
|
|
23,681,019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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ATYR PHARMA INC. |
Condensed Consolidated Balance
Sheets |
(in thousands) |
|
|
|
|
|
|
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|
|
December 31, |
|
|
December 31, |
|
|
|
|
2017 |
|
|
2016 |
|
|
Cash, cash equivalents
and available-for-sale investments |
|
$ |
85,119 |
|
|
$ |
76,149 |
|
|
Other assets |
|
|
1,956 |
|
|
|
2,954 |
|
|
Property and equipment,
net |
|
|
2,280 |
|
|
|
1,421 |
|
|
Total
assets |
|
$ |
89,355 |
|
|
$ |
80,524 |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities |
|
$ |
5,379 |
|
|
$ |
8,186 |
|
|
Current portion of
long-term loans, net of debt issuance costs and discount |
|
|
5,012 |
|
|
|
339 |
|
|
Term loans, net of
current portion and debt issuance costs and discount |
|
|
14,719 |
|
|
|
9,198 |
|
|
Stockholders’
equity |
|
|
64,245 |
|
|
|
62,801 |
|
|
Total
liabilities and stockholders’ equity |
|
$ |
89,355 |
|
|
$ |
80,524 |
|
|
|
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Contact:Mark JohnsonSr.
Director, Investor Relationsmjohnson@atyrpharma.com858-223-1163
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